NCT01867671

Peanut Oral Immunotherapy in Children

Oral Immunotherapy for Induction of Tolerance and Desensitization in Peanut-Allergic Children (ITN050AD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 146 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 12 Months – 48 Months
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled, multi-center study comparing peanut oral immunotherapy (OIT) to placebo in the induction of tolerance and desensitization in peanut-allergic children. Eligible participants with peanut allergy will be randomly assigned to receive either peanut OIT or placebo for 134 weeks followed by peanut avoidance for 26 weeks.

Detailed description

An initial oral food challenge (OFC) to 1 g of peanut flour (500 mg peanut protein) will be conducted. Participants must have a clinical reaction during this OFC to initiate study dosing. After the initial OFC, the study design includes four phases: * Initial dose escalation (1 day): Peanut or placebo dosing will be given incrementally and increase every 20 minutes until a dose of 12 mg peanut flour (6 mg peanut protein) or placebo flour is given. * Build-up (30 weeks): Initial observed dose administration of highest tolerated dose, followed by daily OIT at home with return visit every 2 weeks for dose escalation. * Maintenance (104 weeks):The participant will continue on daily OIT with return visits every 13 weeks. At the end of this phase the participant will undergo a blinded OFC to 10 g peanut flour (5 g peanut protein). * Avoidance (26 weeks): In this final phase participants will be seen every 13 weeks. At the completion of this phase participants will have a final blinded OFC to 10g peanut flour (5 g peanut protein).

Conditions

• Peanut Hypersensitivity

Interventions

Type	Name	Description
BIOLOGICAL	Peanut Oral Immunotherapy - Liquid Extract	Used during initial dose escalation for doses 0.1 to 0.8 mg.
BIOLOGICAL	Placebo for Peanut Oral Immunotherapy - Liquid Extract form	Similar in appearance, texture, and taste to peanut liquid extract.
BIOLOGICAL	Peanut Oral Immunotherapy - Peanut Flour	This will be used for the remainder of dose escalation, build-up, and maintenance.
BIOLOGICAL	Placebo for Peanut Oral Immunotherapy - Peanut Flour	Similar in appearance, texture, and taste to peanut flour.

Timeline

• Start date: 2013-08-13
• Primary completion: 2018-07-02
• Completion: 2018-12-21
• First posted: 2013-06-04
• Last updated: 2020-03-16
• Results posted: 2020-01-22

Locations

5 sites across 1 country: United States